NCT03519750

Pharmacokinetics of Intravenous, Rectal, Intravesical, Vaginal, and Transdermal Melatonin in Healthy Female Volunteers

Pharmacokinetics of Intravenous, Rectal, Intravesical, Vaginal, and Transdermal Administration of Exogenous Melatonin in Healthy Female Volunteers: a Crossover Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Dennis Bregner Zetner · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

Summary

We will investigate the safety and pharmacokinetics of melatonin, when administered rectally, intravesically, vaginally and transdermally. We will recruit 10 healthy female volunteers. The volunteers will have melatonin administered over 5 days; intravenously, rectally, intravesically, vaginally and transdermally. The participants will be followed for 24-48 hours with blood samples and questions about adverse events. There will be a wash-out between each session of a minimum of 7 days.

Conditions

• Melatonin
• Pharmacokinetics
• Safety

Interventions

Type	Name	Description
DRUG	Melatonin 25 mg	24-48 hour monitoring of plasma melatonin as well as adverse events.

Timeline

• Start date: 2018-11-01
• Primary completion: 2019-02-21
• Completion: 2019-02-21
• First posted: 2018-05-09
• Last updated: 2019-04-30

Locations

1 site across 1 country: Denmark